Table 1Summary of the protocol (PICO table)

Population
  • Women diagnosed with a missed miscarriage by pelvic ultrasound scan in the first 14 weeks of pregnancy

Population excludes:

  • Women with a diagnosis of incomplete miscarriage
  • Women opting for alternative methods of miscarriage management (expectant or surgical)
  • Life threatening bleeding

Intervention
  • Mifepristone and misoprostol in combination
Comparison
  • Misoprostol and placebo
Outcome

Critical

  • Failure to spontaneously pass the gestational sac within 7 days after random assignment.
  • Surgical intervention to complete the miscarriage up to discharge from hospital care.

Important

  • Surgical intervention to complete the miscarriage up to and including 7 days after random assignment.
  • Surgical intervention to complete the miscarriage from after day 7
  • and up to discharge
  • Need for further doses of misoprostol within 7 days after random assignment.
  • Need for further doses of misoprostol up to discharge.
  • Infection requiring outpatient antibiotic treatment.
  • Infection requiring inpatient antibiotic treatment.
  • Negative pregnancy test result 21 days (±2 days) after random assignment.
  • Duration of bleeding as reported by the participant (days).
  • Requirement for blood transfusion.
  • Side-effects.
  • Any serious complications.
  • Maternal death

Study design
  • RCT

RCT: Randomised control trial

From: Medical management of miscarriage

Cover of Medical management of miscarriage
Medical management of miscarriage: Ectopic pregnancy and miscarriage: Evidence review D.
NICE Guideline, No. 126.
Copyright © NICE 2023.

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